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HILL v. SEARLE LABS.

May 25, 1988

Connie Hill and William Hill, Plaintiffs
v.
Searle Laboratories, A Division Of Searle Pharmaceuticals, Inc., G.D. Searle & Company; Searle & Company; John Doe I and John Doe II, Defendants



The opinion of the court was delivered by: ROY

 Before the Court is the Motion for Summary Judgment filed by defendants G.D. Searle & Company and Searle & Company. The plaintiff has responded, and the matter is now ripe for determination.

 Plaintiff, Connie Hill, initiated this action alleging that defendant, Searle Laboratories, the manufacturer and supplier of a copper intrauterine device (IUD) called a CU-7 had manufactured/supplied a product which was unreasonably dangerous and/or negligently designed.

 The following statement of facts is drawn from those paragraphs in defendants' statement of material facts which are not disputed by plaintiffs.

 A CU-7 is a copper containing contraceptive manufactured by Searle. It is a prescription drug requiring the order of a physician to be used, and must be inserted by a physician. Information about the CU-7 was submitted to the United States Food and Drug Administration (FDA) in the form of a new drug application (NDA), pursuant to 21 C.F.R. § 310.502.

 In February, 1974 the FDA approved the new drug application, finding the CU-7 to be safe and effective, and granted full approval to Searle to begin marketing the CU-7. The FDA also approved the contents of the package inserts or labeling which accompanied the CU-7 as well as the patient brochure which was subsequently developed.

 In 1977, the FDA promulgated class labeling for use with all IUDs. These regulations mandate the warnings and information which must be provided in the package inserts and patient brochures. 21 C.F.R. § 310.502(b). Searle not only complied with these regulations, it also included additional information.

 Searle's product literature for physicians included the following:

 
Warnings
 
(5) Perforation - Partial or total perforation of the uterine wall or cervix may occur with the use of the CU-7 usually during insertions into patients sooner than 2 months after abortion or delivery, or in the uterine cavities too small for the CU-7. The possibility of perforation must be kept in mind during insertion and at the time of any subsequent examination. If perforation occurs, laparotomy or laparoscopy should be performed as soon as medically feasible and the CU-7 removed. Abdominal adhesions, intestinal penetration, intestinal obstruction and local inflammatory reaction with abscess formation and erosion of adjacent viscera may result if the CU-7 is left in the peritoneal cavity.

 The same labeling also contained this information:

 
Adverse Reactions
 
Perforations of uterus and cervix have occurred. Perforation into the abdomen has been followed by abdominal adhesions, intestinal penetration, intestinal obstruction, local inflammatory reaction with abscess formation and erosion of adjacent viscera.

 (CU-7 package inserts for physicians February, 1981 attached as part of Exhibit D to Searle's Response to Plaintiffs' Interrogatories and Second Request for Production of Documents.)

 Dr. Dennis Davidson, who inserted the IUD in the present case, was fully aware of the risk of perforation associated with the use of a CU-7 or any IUD. Dr. Davidson was also familiar and aware of the contents of the product literature accompanying the CU-7 and believed that it adequately ...


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